Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gianna Wilkie
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation

• Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center

• Patients able to provide written informed consent

Exclusion Criteria:

• Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above

• Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin

• Participants who are under the age of 18

• Multiple Pregnancy

• Patients already taking metformin for other indications

• Fetal defect noted on early dating ultrasound

• Miscarriage before randomization